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The CAR T-Cell Therapy Process | How Care Partners Play a Role in Each Step

 What happens during CAR T-Cell therapy process? Dr. Adriana Rossi, a myeloma specialist, walks through each part of the process and the role that care partners play in each step, emphasizing the importance of communication with the healthcare team.

Dr. Adriana Rossi is Director of the CAR T and stem cell transplant program at the Center for Excellence for Multiple Myeloma at Mount Sinai Health System in New York City. Learn more about Dr. Rossi.

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See More from The Care Partner Toolkit: CAR T-Cell Therapy

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Advice for Myeloma Care Partners | Monitoring for CAR T-Cell Therapy Side Effects

Advice for Myeloma Care Partners | Monitoring for CAR T-Cell Therapy Side Effects

Understanding Your Role as a CAR T-Cell Therapy Care Partner

Understanding Your Role as a CAR T-Cell Therapy Care Partner

CAR T-Cell Therapy | Monitoring for Side Effects As a Care Partner

CAR T-Cell Therapy | Monitoring for Side Effects As a Care Partner 

Transcript:

Jamie Forward:  

Now we’re going to sort of walk through the steps of the CAR T process and what happens in each step, and how the care partner can support the patient during this time. So first, is there a consultation once a patient has been approved for this therapy? 

Dr. Adriana Rossi:  

Absolutely. There are several consultations. The first one, once the patient’s identified by a referring physician, they will come and meet with myself and again, the coordinators and several members of that team to make sure that it seems like a good fit. That this is the right time, and identify any steps that we can take to really set that patient up for success.  

Jamie Forward:  

Okay. And, how can the care partner participate in this meeting? Are there key questions they should be asking? 

Dr. Adriana Rossi:  

Absolutely. Again, this is the beginning of the journey, and they should absolutely be there. Mostly because a lot of the information, this may be the first time they’re hearing again, the words. The concepts. The timeline. So, do ask about when things are going to be happening. As the CAR T physician, I do this all day. So, it’s very clear in my mind, but until it’s clear for them, again, ask more questions. Ask for clarification. 

Be clear on what resources are available. If there’s something that there is a question like transportation, or sequential appointments, or children in the family. All kinds of things. Really be as curious and as vocal as you’re up for.  

Jamie Forward:  

Right. Arranging for childcare and pet care is probably really important during this time. 

Dr. Adriana Rossi:  

Exactly. 

Jamie Forward:  

What about financial planning? Is that a good time to ask about insurance and who to coordinate with there? 

Dr. Adriana Rossi:  

Absolutely. Again, you will meet with social work. But, if there are specific issues that we’ve already identified, specific resources, specific paperwork, we can get that started right away.  

Jamie Forward:  

Okay. Great. So then, after that, once all of that has been squared away and you’re ready to go into the CAR T-cell therapy process, there’s the T-cell collection, correct? 

Dr. Adriana Rossi:  

So again, to distinguish it from stem cells, I think it’s important to know it is a one-day collection for CAR T. 

There are no injections or other preparations ahead of time. There’s no minimum number of cells that we’re aiming to get. It really is a one-day commitment to collect the cells that we collect, because they’ll be then engineered and modified before they’re ready. And so, it’s not the ordeal that sometimes you have to go through for stem cells.  

Jamie Forward:  

Okay. So, the care partner should just be there during that time to be a supportive loved one. 

Dr. Adriana Rossi:  

Exactly. And, it can be a long day. You’re tethered to the machine for a few hours. And, when all goes well, it is an exceedingly boring experience. So, be entertaining and be nearby. Always helpful.  

Jamie Forward:  

That’s great advice. So, once the cells have been collected, can you walk through the next steps? I believe there are bridging treatments involved. Are those administered inpatient or outpatient? 

Dr. Adriana Rossi:  

Absolutely. Bridging therapy is the therapy the patient receives while the cells are out being manufactured. And really, the goal there is not to get rid of myeloma. It’s just to prevent it from growing. Because myeloma that is not cared for tends to grow quite quickly. There are options to do it inpatient. To do it outpatient. There are certain therapies that would require the patients come to our center. Others that are easily given with their local oncologist. So, we really try to find something that the myeloma will be sensitive to, and that will hopefully not be too toxic, so there’s not a big recovery or a big downtime as we are preparing for the hospital stay for CAR T. 

Jamie Forward:  

Okay. And, how can care partners support the patient at home during this time? I would imagine it’s sort of an anxious time. 

Dr. Adriana Rossi:  

Absolutely. Many times, the bridging is something that may be familiar. Like, we’re recycling drugs they’ve seen before.   

But, these could be brand new drugs. And, I think every time you’re experiencing a new cocktail, there is some learning of how will you react, and the anxiety that can come with that, as well. There are a few times when there are delays in the cells getting ready. So, it’s not a very exact day, and that waiting period, wondering will they really come on the day they’re expected absolutely could be an anxious time. I think keeping each other company and just actively working to be your healthiest self for whenever the CAR T is ready, and knowing that working with your physicians, we are all working behind the scenes to work to the greater success hopefully is helpful.   

Jamie Forward:  

And then, finally in the process, the cells are infused back into the patient. Since this is a critical time for patients, how can care partners best be prepared to help their loved one?  

Dr. Adriana Rossi:  

One of the most common side effects is something called CRS. 

Which patients experience as a fever. And, I think many times in blood cancers, we really worry about fevers, because those could be infections. I think it’s important to be prepared and expect the fever so that again, it’s not oh no, what is this? We were waiting for it. It tends to come at a very scheduled time dependent on the product. So, just reassuring. Remembering yes, there are toxicities, but they are expected. Plan for them.

The medical team will have an antidote. We’ll have steps that we take depending on what comes up. And, the reason for being in the hospital is exactly to allow the medical team to respond very quickly. Most of the time, very little happens, and that is wonderful. So, if anyone is feeling bored, that is great. Celebrate it with them. No news is good news during the couple weeks in the hospital.  

Jamie Forward:  

Okay. And, how long is the patient monitored for side effects in the hospital following new infusion?  

Dr. Adriana Rossi:  

So, depends on the product. Ide-cel tends to have very early reactions. And so, our policy is one week for ide-cel (Abecma) and two weeks for cilta-cel (Carvykti) because there, most of the side effects are around seven days in. So, we wait for the inflammation to peak and resolve. And, once it’s safe, we aim to get patients home. But, once they leave the hospital, they should for at least a few weeks be very close to the CAR T center, and usually require two to three visits a week for that close monitoring. 

What Myeloma Care Partners Should Know About Bispecific Antibody Side Effects

 
Dr. Craig Cole reviews the side effects of bispecific antibody therapy, the symptom care partners should be monitoring for, and the importance and impact of early intervention if any issues arise.

Dr. Craig Cole is a multiple myeloma specialist at Karmanos Cancer Institute in Detroit, MI and in East Lansing, MI. Dr. Cole also serves as an associate professor at Wayne State University and at Michigan State University. Learn more about Dr. Craig Cole

See More from The Care Partner Toolkit: Bispecific Antibodies

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Myeloma Care Partners | Understanding Bispecific Antibody Therapy

Myeloma Care Partners | Understanding Bispecific Antibody Therapy

Essential Monitoring Following Bispecific Antibody Therapy for Myeloma

Essential Monitoring Following Bispecific Antibody Therapy for Myeloma

Proactive Steps for Supporting Your Loved One Through Bispecific Antibody Therapy

Proactive Steps for Supporting Your Loved One Through Bispecific Antibody Therapy

Transcript:

Katherine Banwell:

Do side effects vary from patient to patient? 

Dr. Craig Cole:

Yes, so they actually vary greatly from patient to patient and from drug to drug. There’s some bispecifics for some cancers that have low risks of cytokine release so low that they don’t even need to come to the hospital. And some of them have such a high risk of those cytokine release syndromes that people are in the hospital for a few days.  

The other thing is usually the more tumor someone has, the more disease and cancer they have, the higher those risks of cytokine release. And so, it does vary from patient to patient to and from medication to medication. 

Katherine Banwell:

What should care partners understand about caring for someone during therapy? 

Dr. Craig Cole:

One of the big things that care partners should look for or to be aware of are – is the timeline for a lot of those symptoms. The highest risk for the side effects, the things to look out for, the neurologic toxicity, the fevers, and shortness of breath, and things are in the first few days of each dose of receiving therapy.  

Some of those therapies actually because of the neurotoxicity, they don’t let anyone drive, any patients drive for the first few weeks after receiving a bispecific. So, knowing the timeline, that in those first few days, that you really have to check the temperature, have a plan, know who to call, watch for those symptoms. But as the weeks move on, like after the second dose, there’s much less toxicity, third dose, even less risk. Fourth dose and on is very rare to have any of those toxicities, and so then you can relax. And usually people are able to drive. So being aware of the timeline’s important. 

Katherine Banwell:

Yeah. Are there advances being made in the management of side effects for bispecifics? 

Dr. Craig Cole:

Oh yes, and so that’s the – that’s one of the really exciting things is the – is what I was just talking to one of our trainees about this, about the evolution of the bispecific antibodies have been to make them more effective, make them more sticky, make them engage those T cells more while decreasing the toxicities. 

And so the ones that we’re seeing that are in clinical trials now that hopefully will be approved soon have less of those side effects, less hospitalization, and actually have a longer frequency of being given. The other thing is that we’re really beginning to learn a lot about treating cytokine release syndrome, especially as severe cytokine release syndrome. So, there was a drug that was used to treat severe COVID called tocilizumab (Actemra).  

Katherine Banwell:

Yeah.  

Dr. Craig Cole:

And that was used when people came in with COVID symptoms which can be a lot like cytokine release. The would receive this medication to help control that. Now we’re using that to treat cytokine release syndrome.  

And there’s quite a bit of data, especially in multiple myeloma in using it prophylactically to prevent cytokine release syndrome. And there are studies that show that the usual rate in multiple myeloma, kind of the specialty that I have, the usual rate of cytokine release – some cytokine release is about 70 percent with using prophylactic tocilizumab, which is just an antibody against one of those cytokines, IL-6. It goes down to – up to about 25 percent, so 75 to 25.  

And really it has no adverse side effects and doesn’t do anything with the outcome or the effectiveness of the bispecific antibodies.  

Katherine Banwell:

Well, that’s an incredible difference, isn’t it? 

Dr. Craig Cole:

Yes, yes, that was really – the trick is trying to get insurance companies to approve it and to get hospital systems to approve it.  

But I am very confident that very soon as we get more data about using it prophylactically that they’ll be incorporating it into the guidelines. 

Essential Monitoring Following Bispecific Antibody Therapy for Myeloma

Why is a care partner essential for someone undergoing bispecific antibody therapy for myeloma? Dr. Craig Cole, a myeloma specialist, discusses the essential role of care partners following treatment, emphasizing the importance of monitoring for potential side effects. 

Dr. Craig Cole is a multiple myeloma specialist at Karmanos Cancer Institute in Detroit, MI and in East Lansing, MI. Dr. Cole also serves as an associate professor at Wayne State University and at Michigan State University. Learn more about Dr. Craig Cole

See More from The Care Partner Toolkit: Bispecific Antibodies

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What Myeloma Care Partners Should Know About Bispecific Antibody Side Effects

What Myeloma Care Partners Should Know About Bispecific Antibody Side Effects

Being Empowered | Why Care Partner Should Feel Comfortable Voicing Concerns

Being Empowered | Why Care Partner Should Feel Comfortable Voicing Concerns

Bispecific Antibody Therapy | The Important Role of Care Partners

Bispecific Antibody Therapy | The Important Role of Care Partners 

Transcript:

Katherine Banwell:

What is the role of a care partner for someone undergoing bispecific antibody therapy? 

Dr. Craig Cole:

Yeah, the care partner is, I think, a critical component of someone receiving bispecific therapy. And their reason is really to do with the side effects and monitoring the side effects of the therapy. What’s the big side effect of the bispecific antibodies is again when those T cells engage the cancer cells and they find the cancer, they release chemicals to destroy the cancer immediately.  

And those chemicals are from the T cells, can cause people to feel very ill, or can cause them to feel very ill very quickly, or they can have fevers, and they can have difficulty breathing. And that’s called cytokine release syndrome. Cytokines are the chemicals that the T cells are using to kill the cancer cells.  

Release, meaning that T cells are releasing that, and syndrome mean that different things can happen to different people. And the highest risk for the cytokine release syndrome is usually within the first two to three treatments, usually in the first two or three days of the therapy. And a lot of times when people get the bispecific antibodies, sometimes it’s given in a brief hospitalization like an overnight hospitalization, but then they go home.

And then the trick is monitoring for that cytokine release syndrome, the fevers that can be associated with that, shortness of breath, low blood pressure. And in having a couple people observing, watching for those signs and symptoms are really important. Because if cytokine release syndrome isn’t addressed immediately, it can progress to worse outcomes, meaning that the blood pressure gets lower, the difficulty in breathing gets worse.  

If let completely go, people can end up in the intensive care unit which is very, very, very rare. But that’s why we address this as early as possible. The other side effect, and probably kind of the most subtle thing, are some of the neurologic things that can happen with the bispecific antibodies. So, it’s the neurologic toxicity, or some people call it ICANS. And that’s when some of those cytokines that we talked about that are from the T cells can cross the blood brain barrier and cause patients to be confused.  

They can have word finding difficulties. They can feel – almost have stroke-like symptoms. They’re temporary, but they definitely need to be addressed. And sometimes patients may not be aware that they can’t find the right word, or they want to speak, and the words don’t come out, or when they speak it’s the wrong words are coming out.  

And that’s a real, real big sign that you need to call your doctor immediately, or your provider immediately if you have those neurologic symptoms. So, watching for those side effects, so low blood pressure, the high fevers, and stroke like symptoms. It’s not a stroke, but it’s just those chemicals in the brain that can cause people to have some neurologic problems. And again, if you address those immediately, they are definitely reversible.  

What Are the Risks of CAR T-Cell Therapy?

What Are the Risks of CAR T-Cell Therapy?  from Patient Empowerment Network on Vimeo.

Dr. Melissa Alsina, a myeloma expert from Moffitt Cancer Center, reviews the potential side effects of CAR T-cell therapy for myeloma patients, and discusses how these side effects may be managed.

Dr. Melissa Alsina is an associate professor of medicine in the Blood and Marrow Transplant Program at Moffitt Cancer Center in Tampa, Florida where she also serves as head of the Multiple Myeloma Transplant Program. Learn more about Dr. Alsina, here.

See More from Innovative Myeloma Therapies

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Myeloma Research | CAR-T Cell & Bispecifics Study Updates

Myeloma Research | CAR-T Cell & Bispecifics Study Updates

How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape?

How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape?

What Are Common Myeloma Treatment Side Effects?

Transcript:

Katherine:

What are the risks of CAR T-cell therapy? 

Dr. Alsina:

So, in myeloma, it is, in general, pretty safe. There are two main – well, actually, I would say three main side effects that we can see with CAR-T. Number one is called cytokine release syndrome, and we are getting these cells from the patient’s immune systems, sending them a lab to be manufactured so that they can recognize this protein, BCMA, in the myeloma cells. 

And then, those cells are grown, so essentially, what we’re doing is that we’re taking the immune system of the patient, and we’re making it very specific against the myeloma cell. And then we’re growing it, so we’re making a hyperactive immune system, and then giving it back to the patient. And then, those cells, they are going to go ahead and react against the myeloma cells and start killing the myeloma cells, and in doing that, that reaction, that immune reaction will elicit release of a lot of proteins – cytokines – and that can cause side effects. 

When that happens, that is called cytokine release syndrome, and the most common finding with that is a fever. Patients can have a high fever. And then, it varies depending on the CAR-T that the patients are getting. So, for example, with this Abecma, usually, the reaction happens right away after you get the cells – the next day, so that’s why these patients, we admit them to the hospital because we know that this cytokine release syndrome is going to happen right away.  

And, it could be just a fever. In the majority of the patients, it happens like this, is just a fever, but it may be about 20 percent of the patients, that reaction can be more severe, and it could be a fever with low blood pressure or shortness of breath, and it could be a fatal complication, but that’s very, very rare.  

And we know – we can identify, obviously, when it’s happening, and there’s a medication that we can give to actually sort of counteract that reaction and don’t let it progress, and in the majority of the patients, that works quite well.  

Katherine:

What other side effects are there for CAR T-cell therapy? 

Dr. Alsina:

Yeah, so besides the main one that I discussed, cytokine release syndrome, the other thing that could happen is neurotoxicity, meaning that T cells can actually cross to the brain and cause toxicity in the brain, and depending on the type of CAR-T that the patient is getting, it could be less or more risk.  

But essentially, what could happen is that the patient could have some aphasia, like for example, difficulty finding words. It could also be just a headache. Patients could have seizures, so we do give the patients medication to prevent seizures while they are undergoing CAR-T. 

They can have difficulty writing, so we make every patient write a sentence every day to make sure that’s not being affected. And we do a mini mental status every day. Every day, we’ll go see the patient and ask them 10 different questions, like “Where are you? What day is it? Who’s the president?”, we show them an object, and so on so we can monitor these things very closely. If we see any changes, then we can intervene. Usually, for neurotoxicity, we give steroids. 

The good news, though, is that this is very rare. With Abecma, it’s very rare that a patient would have severe neurotoxicity. With ciltacabtagene autoleucel (Carvykti), which is the one that was approved more recently, from 100 patients that were treated, there were five patients that had this delayed neurotoxicity, some of them with movement disorders, like Parkinson’s-like systems, and these were delayed. These didn’t happen in the first few weeks. 

But we learned what are the risks associated with these, the majority of the patients that have very high tumor burden, so what we do is that we monitor the patients very closely, especially the patients with high tumor burden. The ideal situation is that we can control the disease a little bit better before taking them to CAR-T, but even when that’s not possible, what we do is that we intervene early on if we see that these patients are getting any side effects and being more aggressive with the intervention. 

And then, the third, more important side effect is these CAR-T cells can prevent blood counts to recover. For CAR-T, we give chemotherapy.  

That would allow the T cells to expand, and this chemotherapy can drop the blood counts, but usually, they recover quickly, but in some patients, this recovery doesn’t happen quickly, and patients can have low counts for months, and obviously, that would bring increased risk of infection. 

So, that is a potential complication, especially in patients that have received a lot of prior therapies, and it’s not common that a patient would take a long time, but it could happen, and sometimes, occasionally, we’ve had to give these patients a stem cell boost from stem cells that we have stored to actually make their counts recover. So, those are essentially the three most common complications, but in general, it’s a treatment that is well tolerated and very manageable, and I can tell you the majority of the patients that I’ve treated, they’ve said this is easier than a transplant.